P2P Missteps Continue

There are new developments in the continuing saga that is the NIH’s Office of Disease Prevention’s mismanagement of public comment on the P2P report. When I last wrote about this on April 3rd, ODP had acknowledged that yes indeed, they had failed to send an unspecified number of comments to the Panel. In an attempt to reassure us, ODP said that publication of the report would be delayed so the Panel could review the missing comments and decide if they should change anything in the report.

On April 7th, I received a second release of documents under my FOIA request, described as consisting of all the remaining comments. But that was not true. I carefully reviewed the documents and compared them with what was submitted to me for the P2P Library. I asked another advocate to double check my work. There are still comments missing – I can document at least six. I filed a second appeal on April 13th, but then on April 16th, ODP announced that the final report would be published on June 16, 2015.

There are several possibilities:

Maybe those six comments were not received by NIH. But I was copied on the actual emails to NIH in several cases, so that is not likely to be the case.

Maybe those six comments were sent to the Panel, but not sent to the FOIA office for release to me. This would represent a continuing and disturbingly lax approach to document management.

Maybe those comments were not sent to the Panel when the rest of the missing “set” was sent to them after I uncovered the problem. This is the worst possibility of all.

We are left with difficult questions about the integrity and validity of the process:

Has the Panel received all the comments, or are there still some missing?

How much time was the Panel given to consider the set of comments sent to them a few weeks ago?

Did the Panel take the time to reconsider all the public comment? Or did they simply read the new ones?

Whatever is in the final report, how can we be sure it is the best version that would have resulted if ODP had not screwed up the public comment process to begin with?

The mishandling of public comments is not a technicality, nor is it an insignificant matter. This goes to the heart of NIH’s stewardship of a process that depends upon the opinions of five people who have no expertise in ME/CFS. The federal government cannot play fast and loose with public comment, no matter what that final report looks like.

On April 19th, I sent a letter to the Office of the Inspector General for the Department of Health and Human Services to request an investigation and intervention to remedy the problem. After describing the facts of the situation, I wrote:

ODP’s failure to forward over 200 pages of public comment to the P2P panel for consideration is a clear violation of the public trust, NIH’s document retention policies, and public comment administrative procedures. The proposed “fix” of asking the panel “to consider the new information and determine if changes are needed before the release of the final report” is completely inadequate.

The purpose of collecting public comment is for the panel to have the benefit of outside views. By design, the P2P process selects non-subject matter experts for the panel. In order to produce useful recommendations on the future needs of ME/CFS research, the panel is completely dependent on the multi-component process of presenting evidence, particularly the public comment submitted on the draft report.

However, the success of the process requires that all public comments on the P2P report be considered equally. They should be compared and contrasted, and given equal weight. By failing to provide the Panel with all of the comments at the same time, NIH has created a situation in which the missing comments will automatically be considered differently than the comments sent to the Panel in January. This error is only compounded by the apparent failure to find all of the misplaced comments and produce them under FOIA. Finally, only two weeks elapsed between ODP’s acknowledgement of its failure to provide the comments to the panel and the announcement of the new publication date. It remains unknown whether the panel has received all the comments, how much time they have had to review the comments, and whether all the comments have been given the same level of scrutiny and consideration.

Given ODP’s admission that the panel did not receive all of the public comment, the very legitimacy of the P2P process and final report is undermined. This report is highly relevant to the planning and conduct of future ME/CFS research at NIH. There is a strong public interest in ensuring that NIH takes every appropriate corrective step, and that new procedures are in place to prevent the repetition of these errors.

Therefore, I ask that your office investigate the handling of public comment by ODP. I further ask that you act immediately to intervene, given the imminent publication of the panel’s final report. The report should not be published until the panel has received and given due consideration to every single comment submitted by the public in response to NIH’s invitation.

I will keep you posted on the status of my FOIA appeal and on any reply I receive from the OIG.

18 Responses to P2P Missteps Continue

Slightly off topic – Remember the erroneous version of CFSAC’s recommendations for a workshop to update and adopt the CCC? Apparently that’s the version that went to the IOM. Listen to the beginning of this talk by Dr. Clayton at the meeting in DC arranged by SMCI last week:

I’m too sick to write a detailed response, but the CFSAC recommendation on case definition was not altered after the public vote and before it was sent to the Secretary. However, it is quite accurate to say that the IOM contract was not what CFSAC recommended. I’m sorry I’m too sick to write up the documentation I have on this.

Thank you for being on the case and following up. This continues to be scandalous in my opinion. Wonder what we can do now? My unconscious brain is saying, “We need a temporary injunction to stop the P2P report from being finalized until all comments are included and fairly considered.”
So glad you caught this and wonder what will happen without legal intervention.
Your calling attention to this mishap or worse is very helpful. But now what?
Take care of your health though. What’s going on is enough stress to exacerbate ME/CFS.

May I humbly suggest that a copy of your communication to the Inspector General be copied to Ms. Burwell with a small note to make it a new communication? Perhaps to a few of your or Mary Dimmock’s targeted legislators as well, pointing out that the gang can’t shoot straight and yet are paid from the American taxpayers’ purse. The IG spends 80% of time on Medicare and Medicaid and I believe a bit on Native Americans as well, so we are unlikely to get a timely response. To put it mildly.

Amen, I cannot thank you enough for your diligence in holding this committee accountable! It is a shame that those suffering in their beds and often struggling for their next breath are the ones who have to hold these perfectly, healthy individuals accountable to properly manage this enormous and precious task which they been entrusted with!

Thank you! Your tenacity has to be congratulated, I honestly don’t know how you do it.
This whole thing has been a huge frustration to all of us that will be effected by this “unbiased” panels report. Grrrrrr!
Please take care of yourself. Thank you SO VERY MUCH for your devotion to the cause.

Wow, what a bunch of dummies! These people must’ve gone to college at the Keystone Cops School of MisManagement.

Yesterday I received a CD containing the second batch of P2P comments. I was really surprised, because I never sent HHS a request for the second batch. So it appears to me that somebody is trying to fix the problem – they’re just not having much success.

Thank you for continuing to keep us informed about the missing P2P public comments. Your letter to the HHS Inspector General certainly explained the problem well. I hope he is willing to investigate and intervene.

Below are two letters that I sent regarding this problem. They incorporate some of your concepts. Thank you.

LETTER ONE: Letter one, dated April 27, 2015, was to the five P2P Panel members and Dr. James Anderson at NIH with copies to Secretary Burwell and Dr. Collins.

This is a follow-up to my email on 4-9-2015 regarding the initial mistake disclosed on 4-2-2015 that the Office of Disease Prevention (ODP) had not forwarded to the P2P Panel all of the “public comments.”

That raises the question of whether the Panel has received all of the comments, or whether some are still missing.

The mishandling of public comments by ODP is a significant matter. It potentially undermines the validity of the Report.

Thus, it unfortunately, places an additional responsibility on the P2P Panel to ascertain that it has received all public comments.

I am also concerned that the ODP has announced a new Report publication date of 6-16-2015. Again, it places responsibility on the Panel to make sure it has sufficient time to review all the comments and to make sure that all the public comments have been given the same level of scrutiny and consideration.

The Report should not be published until the Panel has received and given due consideration to every public comment.

If the Panel cannot accomplish this by the current publication deadline, it is incumbent upon the Panel and Dr. Anderson to again postpone the Report publication.

It is my hope that Dr. Anderson is actively involved in solving the mistakes and preventing repetition of these errors.

As I explained in my previous email, my interest in the P2P process and the integrity of the final P2P Report is based on the fact that my daughter has suffered from ME/CFS since October 31, 2005. I am hopeful that the P2P Report along with the Institute of Medicine (IOM) Report will focus attention on this disease and significantly increase NIH funding and research to find a cure.

The final P2P Report will be critically important in addressing additional NIH funding for medical research into the cause and cure of ME/CFS. Thus, it is imperative that the P2P Report take into account all public comments in order to provide a complete and accurate assessment of the ME/CFS public health crisis.

My interest in the P2P process and the integrity of the final P2P Report is based on the fact that my daughter has suffered from ME/CFS since October 31, 2005. I am hopeful that the P2P Report along with the Institute of Medicine (IOM) Report will focus attention on this disease and significantly increase NIH funding and research to find a cure.

In order to ensure the integrity of the P2P Report, I believe it is important for you to be aware of the mismanagement by NIH’s Office of Disease Prevention (ODP) of the “Public Comments” on the 2014 NIH Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS).

As background, ME/CFS per the February, 2015 Institute of Medicine (IOM) Report is:
“… a serious, chronic, complex, and systemic disease that frequently and dramatically limits the activities of affected patients. In its most severe form, this disease can consume the lives of those whom it afflicts. It is ‘real’.” (Page 5.)

The Report further states that “… the committee was struck by the relative paucity of research on ME/CFS conducted to date. Remarkably little research funding has been made available to study the etiology, pathophysiology, and effective treatment of this disease, especially given the number of people afflicted.” (Page 9.)

The IOM Report states that ME/ CFS “… affects somewhere between 836,000 and 2.5 million Americans.” (Page 15.)

For FY 2015 NIH lists 244 Research/Disease Areas. Of the 244 areas three (3) receive zero funding and twelve (12) receive funding of $5 million or less. Thus, of the 241 funded areas ninety-five percent (95%) receive funding greater than the estimated $5 million support level for ME/CFS.

The level of ME research funding demands serious review and correction by NIH leadership.

The final P2P Report will be critically important in addressing additional NIH funding for medical research into the cause and cure of ME/CFS. Thus, it is imperative that the Report take into account all public comments in order to provide a complete and accurate assessment of the ME/CFS public health crisis.

It is my understanding that over 200 pages of “public comments” were not initially forwarded to the P2P Panel for consideration. The mishandling of public comments by ODP is a significant matter. It potentially undermines the validity of the Report.

First, I urge you to request the Office of the Inspector General for the Department of Health and Human Services to investigate the handling of the P2P public comments by ODP.

Secondly, given the fact that the ODP has announced it intends to publish the P2P final report on June 16, 2015, I ask that you intervene immediately to ascertain whether the P2P Panel has received all the comments; whether they have had sufficient time to review the comments; and whether all comments have been given the same level of scrutiny and consideration.

The Report should not be published until the Panel has received and given due consideration to every public comment.